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The Nature of Reflux-respiratory Symptoms Association in Difficult to Treat Wheezing\Coughing Babies

The Nature of Reflux-respiratory Symptoms Association in Difficult to Treat Asthmatic/Wheezing Babies Using Impedance and Wheezy Monitoring

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00512382
Enrollment
15
Registered
2007-08-07
Start date
2007-03-31
Completion date
2011-09-30
Last updated
2011-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Cough, Wheezing

Keywords

GER Gastrointestinal reflux, Aspiration, ASHTMA, COUGH, WHEEZE, PH-IMPEDANCE, WEEM Wheezy Monitor

Brief summary

GER and respiratory symptoms are both common phenomenon in children. Both can coexist in the same patient by chance alone. Research reveals increased incidence for both to coexist leading to suspect a temporal association and possible causality. Therefore we conducted an observational study To determine the primary cause (RS or GER)using for the first time both PH-Impedance as measurements of GER and Wheezy monitoring (WEEM) that records simultaneously wheeze and cough noises. Both modalities will be recorded for 12-24 hours. If GER precedes cough/wheeze recordings it points to GER being the possible precipitating factor and vice versa.

Detailed description

GER and respiratory symptoms are both common phenomenon in children. Both can coexist in the same patient by chance alone. Research reveals increased incidence for both to coexist leading to suspect a temporal association and possible causality. Therefore we conducted an observational study To determine the primary cause (RS or GER)using for the first time both PH-Impedance as measurements of GER and Wheezy monitoring (WEEM) that records simultaneously wheeze and cough noises. Both modalities will be recorded for 12-24 hours. If GER precedes cough/wheeze recordings it points to GER being the possible precipitating factor.However, If cough/wheeze precedes GER recordings it points to cough/wheeze being the possible precipitating factor. The recordings will be investigated 1 minute before and one minute after each event.

Interventions

DEVICEWEEM - Wheezy Monitoring

loudspeaker recording (WEEM) is attached externally to the chest simultaneously with PH-Impedance.

Sponsors

Wolfson Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Months
Healthy volunteers
Yes

Inclusion criteria

* Children 1 month - 18 years old * Difficult to treat asthma * Difficult to treat cough * Difficult to treat other respiratory symptoms

Exclusion criteria

* Children on artificial ventilation * Children not compliant with PH-Metria and/or WEEM

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026